Glossary Term

Disapproval

Review & Determinations

Also known as: disapproved, IRB disapproval

A formal IRB determination that a study cannot be approved as submitted; the investigator must be informed in writing of the reasons.

Per 45 CFR 46.109(d) and 21 CFR 56.109(e), the IRB must provide written reasons for any disapproval and offer the investigator an opportunity to respond. Disapproval may be overcome by substantial revision and re-submission.

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